A Phase 4 interventional study of Marketed Denture Adhesive (Super Poligrip Max Seal) and No Adhesive in Denture Retention, sponsored by GlaxoSmithKline. Completed at 1 site in United States. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2020-03-02.
Sponsored by GlaxoSmithKline · Phase 4, Interventional, and Supportive care
The purpose of this study is to determine the ability of a marketed denture adhesive to restrict food ingress underneath dentures during eating.
This is a single center, controlled, single-blind, randomized, two-treatment, two-period, cross-over design in participants with full upper and lower dentures. The study hypothesis is that this methodology will enable comparisons between denture adhesives and no adhesive to demonstrate the effectiveness of denture adhesives in restricting food ingress under dentures during eating. This study will consist of three visits: Visit 1 - Screening Visit; Visit 2 - Treatment 1 Visit; Visit 3 - Treatment 2 Visit. Participants will use test product which is a marketed denture adhesive (Super Poligrip Max Seal [SPMS]) (application will be controlled by weight) to the dentures in a pattern of continuous strips which will be applied to upper and lower denture and will be then placed in mouth and participants will also use no adhesive as a control. Participants will cross-over between treatments so that all participants will participate in all 2 treatment arms. An hour after the participant has worn their denture, they will chew a portion of peanuts in a controlled manner. After a rinsing procedure with water, the dentures will be removed, and any peanuts that have been migrated under each denture will be collected and weighed after a drying process. Participants will also answer a short questionnaire on the procedure and record the number of times their denture dislodged during the chewing procedure. The number of denture dislodgments reported by the participants during the chewing of the peanuts will also be collected and analyzed and this, and the questionnaire data, will be used to support the findings of the peanuts mass measure.
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Of its 258 completed or terminated interventional studies of FDA-regulated products, 232 (90%) have results posted.
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Exclusion Criteria:
Test denture adhesive will be applied directly from the tubes using a continuous strip pattern to the upper and lower denture which will then be placed in mouth of the participants.
Combination Product: Marketed Denture Adhesive (Super Poligrip Max Seal)
Participants will not apply any denture adhesive in this treatment arm.
Other: No Adhesive
The denture adhesive will be applied directly from the tubes. 1.6 g of adhesive per treatment will be applied to each participant's dentures. This dose will be split as 1.00±0.1 g for the maxillary and 0.6±0.1g for the mandibular dentures.
No adhesive will be applied.
Food Occlusion Analysis of Combined Mass of Peanuts Under Combined Maxillary (Upper) and Mandibular (Lower) Dentures
On each test day(Visit2,3)participants underwent an Oral Soft Tissue (OST) exam,dentures cleaned using denture cleanser.Product application controlled by weight:1g(+/-0.1g)to upper denture ,0.6g (+/-0.1g)to lower denture by dispensing staff. After60+/-5minutes(min) of replacing denture in the mouth,participants consumed 30-32g of non-salted peanuts, divided into smaller portions of approximately(app) 8nut halves. Each portion was chewed for app20 seconds(sec). After which mouth rinsed with water for app10sec. Both upper and lower dentures were removed,any nuts remaining in mouth were collected using gauze.Dentures and gauzes placed in beaker with warm de-ionized water and sonicated for 30min,water was strained by sieve.Collected nuts washed,air-dried and transferred to pre-weighed aluminium weighing pans,dried at 40-degree Celsius (deg C)for 5 hours(h). Pans removed,cooled to room temperature,weighed to determine mass of nuts collected from each denture.
Time frame: Upto 16 days
Food Occlusion Analysis of Mass of Peanuts Under Maxillary Denture
On each test day (Visit2,3) participants underwent an OST exam, dentures cleaned using denture cleanser. Product application controlled by weight:1g(+/-0.1g)to upper denture ,0.6g (+/-0.1g)to lower denture by dispensing staff. After 60+/-5 min of replacing denture in the mouth, participants consumed 30-32g of non-salted peanuts, divided into smaller portions of app 8nut halves. Each portion was chewed for app20 sec. After which mouth rinsed with water for app10sec. Both upper and lower dentures were removed, any nuts remaining in mouth were collected using gauze. Dentures and gauzes placed in beaker with warm de-ionized water and sonicated for 30min, water was strained by sieve. Collected nuts washed, air-dried and transferred to pre-weighed aluminium weighing pans, dried at 40-deg C for 5h. Pans removed, cooled to room temperature, weighed to determine mass of nuts collected from each denture.
Time frame: Upto 16 days
Food Occlusion Analysis of Mass of Peanuts Under Mandibular Denture
On each test day (Visit2,3) participants underwent an OST exam, dentures cleaned using denture cleanser. Product application controlled by weight:1g(+/-0.1g)to upper denture ,0.6g (+/-0.1g)to lower denture by dispensing staff. After 60+/-5 min of replacing denture in the mouth, participants consumed 30-32g of non-salted peanuts, divided into smaller portions of app 8nut halves. Each portion was chewed for app20 sec. After which mouth rinsed with water for app10sec. Both upper and lower dentures were removed, any nuts remaining in mouth were collected using gauze. Dentures and gauzes placed in beaker with warm de-ionized water and sonicated for 30min, water was strained by sieve. Collected nuts washed, air-dried and transferred to pre-weighed aluminium weighing pans, dried at 40-deg C for 5h. Pans removed, cooled to room temperature, weighed to determine mass of nuts collected from each denture.
Time frame: Upto 16 days
Number of Denture Dislodgements During Chewing as Reported by Participants
On each test day (Visit 2,3) participants had an OST exam and their dentures were cleaned before study product was applied to the dentures. 1g (+/-) was applied to the upper denture and 0.6g (+/-) was applied to the lower dentures by dispensing staff. After insertion of the dentures into participants mouths, they were required to wait 60 mins (+/- 5mins) after which they were required to chew 30-32g of non-salted peanuts, divided into smaller portions of approximately 8 nut halves. Participants were required to chew each portion of peanuts for approximately 20 secs. Whilst consuming the peanuts, participants were required to tick a box every time they felt their denture dislodge. The total number of dislodgments were recorded by study site staff.
Time frame: Upto 16 days
Mean Scores From Participant Completed Questionnaire
On each test day(Visit 2,3)participants underwent an OST exam,dentures cleaned using denture cleanser. Product application controlled by weight:1g(+/-0.1g)to upper denture,0.6g (+/-0.1g)to lower denture by dispensing staff. After 60+/-5min of replacing denture in the mouth, participants consumed 30-32g of non-salted peanuts, divided into smaller portions of app8nut halves. Each portion chewed for app20 sec. After eating all,participants answered a questionnaire for chewing experience by questions (Q):Q1,were you aware of nuts pieces under your denture:yes/no.Participants answered no to Q1 were not required to answerQ2,3;they were automatically assigned 0 score for Q2,3. Participants who answered yes to Q1 were asked Q2,3;Q2,rate amount of nuts pieces under your denture on0-10scale;Q3,how bothered were you by nuts pieces went under your denture on0-10scale.Q2score:0=none,10=lots of nuts pieces;Q3score:0=not at all bothered,10=extremely bothered. Lower scores indicate better results.
Time frame: Upto 16 days
Participants were recruited from a single center in the United States. A total of 53 participants were screened, of which 49 were enrolled. 48 participants were randomized and completed the study.
| Milestone | Sequence 1 | Sequence 2 |
|---|---|---|
| Started | 24 | 24 |
| Completed | 24 | 24 |
| Not completed | 0 | 0 |
| Milestone | Sequence 1 | Sequence 2 |
|---|---|---|
| Started | 24 | 24 |
| Completed | 24 | 24 |
| Not completed | 0 | 0 |
On each test day(Visit2,3)participants underwent an Oral Soft Tissue (OST) exam,dentures cleaned using denture cleanser.Product application controlled by weight:1g(+/-0.1g)to upper denture ,0.6g (+/-0.1g)to lower denture by dispensing staff. After60+/-5minutes(min) of replacing denture in the mouth,participants consumed 30-32g of non-salted peanuts, divided into smaller portions of approximately(app) 8nut halves. Each portion was chewed for app20 seconds(sec). After which mouth rinsed with water for app10sec. Both upper and lower dentures were removed,any nuts remaining in mouth were collected using gauze.Dentures and gauzes placed in beaker with warm de-ionized water and sonicated for 30min,water was strained by sieve.Collected nuts washed,air-dried and transferred to pre-weighed aluminium weighing pans,dried at 40-degree Celsius (deg C)for 5 hours(h). Pans removed,cooled to room temperature,weighed to determine mass of nuts collected from each denture.
| Milligrams (mg) | Experimental Denture Adhesive | No Adhesive |
|---|---|---|
| Food Occlusion Analysis of Combined Mass of Peanuts Under Combined Maxillary (Upper) and Mandibular (Lower) Dentures | 5.56 (3.72 to 8.31) | 29.13 (19.48 to 43.56) |
On each test day (Visit2,3) participants underwent an OST exam, dentures cleaned using denture cleanser. Product application controlled by weight:1g(+/-0.1g)to upper denture ,0.6g (+/-0.1g)to lower denture by dispensing staff. After 60+/-5 min of replacing denture in the mouth, participants consumed 30-32g of non-salted peanuts, divided into smaller portions of app 8nut halves. Each portion was chewed for app20 sec. After which mouth rinsed with water for app10sec. Both upper and lower dentures were removed, any nuts remaining in mouth were collected using gauze. Dentures and gauzes placed in beaker with warm de-ionized water and sonicated for 30min, water was strained by sieve. Collected nuts washed, air-dried and transferred to pre-weighed aluminium weighing pans, dried at 40-deg C for 5h. Pans removed, cooled to room temperature, weighed to determine mass of nuts collected from each denture.
| mg | Experimental Denture Adhesive | No Adhesive |
|---|---|---|
| Food Occlusion Analysis of Mass of Peanuts Under Maxillary Denture | 1.39 (0.92 to 2.11) | 8.17 (5.39 to 12.38) |
On each test day (Visit2,3) participants underwent an OST exam, dentures cleaned using denture cleanser. Product application controlled by weight:1g(+/-0.1g)to upper denture ,0.6g (+/-0.1g)to lower denture by dispensing staff. After 60+/-5 min of replacing denture in the mouth, participants consumed 30-32g of non-salted peanuts, divided into smaller portions of app 8nut halves. Each portion was chewed for app20 sec. After which mouth rinsed with water for app10sec. Both upper and lower dentures were removed, any nuts remaining in mouth were collected using gauze. Dentures and gauzes placed in beaker with warm de-ionized water and sonicated for 30min, water was strained by sieve. Collected nuts washed, air-dried and transferred to pre-weighed aluminium weighing pans, dried at 40-deg C for 5h. Pans removed, cooled to room temperature, weighed to determine mass of nuts collected from each denture.
| mg | Experimental Denture Adhesive | No Adhesive |
|---|---|---|
| Food Occlusion Analysis of Mass of Peanuts Under Mandibular Denture | 2.75 (1.63 to 4.64) | 13.07 (7.75 to 22.02) |
On each test day (Visit 2,3) participants had an OST exam and their dentures were cleaned before study product was applied to the dentures. 1g (+/-) was applied to the upper denture and 0.6g (+/-) was applied to the lower dentures by dispensing staff. After insertion of the dentures into participants mouths, they were required to wait 60 mins (+/- 5mins) after which they were required to chew 30-32g of non-salted peanuts, divided into smaller portions of approximately 8 nut halves. Participants were required to chew each portion of peanuts for approximately 20 secs. Whilst consuming the peanuts, participants were required to tick a box every time they felt their denture dislodge. The total number of dislodgments were recorded by study site staff.
| Number of denture dislodgements | Experimental Denture Adhesive | No Adhesive |
|---|---|---|
| Number of Denture Dislodgements During Chewing as Reported by Participants | 0.0 (0 to 10) | 4.0 (0 to 28) |
On each test day(Visit 2,3)participants underwent an OST exam,dentures cleaned using denture cleanser. Product application controlled by weight:1g(+/-0.1g)to upper denture,0.6g (+/-0.1g)to lower denture by dispensing staff. After 60+/-5min of replacing denture in the mouth, participants consumed 30-32g of non-salted peanuts, divided into smaller portions of app8nut halves. Each portion chewed for app20 sec. After eating all,participants answered a questionnaire for chewing experience by questions (Q):Q1,were you aware of nuts pieces under your denture:yes/no.Participants answered no to Q1 were not required to answerQ2,3;they were automatically assigned 0 score for Q2,3. Participants who answered yes to Q1 were asked Q2,3;Q2,rate amount of nuts pieces under your denture on0-10scale;Q3,how bothered were you by nuts pieces went under your denture on0-10scale.Q2score:0=none,10=lots of nuts pieces;Q3score:0=not at all bothered,10=extremely bothered. Lower scores indicate better results.
| Score on scale | Experimental Denture Adhesive | No Adhesive |
|---|---|---|
| Amount of peanut pieces under denture | 0.8 ± 0.29 | 3.8 ± 0.52 |
| Bothered by peanut pieces under denture | 0.7 ± 0.28 | 4.0 ± 0.57 |
Collected over From signing of the informed consent form until 5 days after last administration of study drug (or last procedure). Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Experimental Denture Adhesive | 0/48 (0%) | 0/48 (0%) | 2/48 (4.2%) |
| No Adhesive | 0/48 (0%) | 0/48 (0%) | 4/48 (8.3%) |
| Event | Experimental Denture Adhesive | No Adhesive |
|---|---|---|
| Oral hyperkeratosisGastrointestinal disorders | 1/48 | 2/48 |
| Mouth InjuryInjury, poisoning and procedural complications | 0/48 | 1/48 |
| Traumatic ulcerInjury, poisoning and procedural complications | 0/48 | 1/48 |
| Tongue bitingNervous system disorders | 1/48 | 0/48 |
Safety Population (N=48) included all randomized participants who received at least 1 dose of the study product.
| Age, Continuous(Years) | Overall |
|---|---|
| Mean | 65.1 ± 10.77 |
| Sex: Female, Male(Participants) | Overall |
|---|---|
| Female | 33 |
| Male | 15 |
| Ethnicity (NIH/OMB)(Participants) | Overall |
|---|---|
| Hispanic or Latino | 2 |
| Not Hispanic or Latino | 46 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | Overall |
|---|---|
| American Indian or Alaska Native | 1 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 4 |
| White | 43 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
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